Proven non-invasive treatment for oa

Indications For BioniCAre
History of BioniCare Technology
The BioniCare Knee System is indicated for use as an
adjunctive therapy in reducing the level of pain and
symptoms associated with osteoarthritis of the knee and
for overall improvement of the knee as assessed by the
Physician’s Global Evaluation (clinical studies).
1985
1986
1990
1993
1997
1999
2003
Contraindications
–
–
–
–
–
–
–
FDA IDE G850158 for arthritis trials
Osteoarthritis and RA trials initiated
FDA PMA P900055 filed for OA Knee
FDA Non-Significant Risk Letter
FDA 510(k) Clearance for OA Knee
FDA 510(k) Clearance for RA Hand
FDA 510(k) Clearance for Dual OA Knee
• Do not use the BioniCare Knee System for any electrode
placement that applies current to the carotid sinus
(neck) region.
• Do not use the BioniCare Knee System for any electrode
placement that causes current to flow transcerebrally
(through the head).
References
1
Zizic TM, Hoffman KC, et al. “Treatment of Osteoarthritis of the Knee with
Pulsed Electrical Stimulation” Journal of Rheumatology 1995, Vol 22
Issue 9, Pages 1757-1761
2
Mont MA, Hungerford DS, et al. “Pulsed Electrical Stimulation to Defer TKA
in Patients with Knee Osteoarthritis.” Orthopedics. October 2006 (10):
887-892
3
Harrington TJ, et al. Synergy Paper, “New Options for Treating Osteoarthritis
of the Knee.” Supplement to Rheumatology News Nov 2011.
• Do not use the BioniCare Knee System when pain
syndromes are undiagnosed until etiology is established.
Precautions
Isolated cases of skin irritation may occur at the site of
electrode placement following long-term application.
Adverse Reactions
Skin irritation and electrode burns are potential adverse
reactions. Patients with skin irritation / reactions should
be monitored.
WARNINGS
• The BioniCare Knee System must be used only as
prescribed and applied only to the knee.
• Patients with demand style cardiac pacemakers should
consult with their physician prior to use of this system.
• The safety of the BioniCare Knee System for use during
pregnancy or birth has not been established.
• The BioniCare Knee System is not effective for pain
of central origin (including headache).
• Use only under the continued supervision of a physician.
• Keep out of reach of children.
• Electronic monitoring equipment (such as ECG monitors
and ECG alarms) may not operate properly when the
BioniCare Knee Device is in use.
Indications For OACTIVE and Eagle OA
• Mild to severe unicompartmental knee osteoarthritis.
• Medial or lateral compartment.
WARNINGS
If you experience pain, swelling, sensation changes,
or unusual reactions while using this product, contact
VQ OrthoCare’s Patient Care department at
800.452.7993 or consult a physician.
CAUTION
Federal law restricts this device to sale by or
on the order of a practitioner licensed by the
law of the State in which he/she practices to
use or order the use of the device.
www.bionicare.com
18011 Mitchell South • Irvine, CA • 92614
800.266.6969 • www.vqorthocare.com
© 2011 VisionQuest Industries, Inc.
VQO511536REVG
Proven non-invasive treatment for OA
According to its FDA clearance, BioniCare® is the only treatment available that provides an overall
improvement to the osteoarthritic knee as assessed by the physician’s global evaluation. More than
5,000 physicians have treated over 80,000 osteoarthritis patients with the BioniCare Knee System and
the results have been outstanding. While the peer-reviewed, published scientific evidence supporting
the efficacy of BioniCare is compelling, the positive patient outcomes speak for themselves.
TWO ELECTRODES
BioniCare’s clinically
proven signal is delivered
through advanced technology electrodes that
avoid the need for messy
conductive gel. Extensive
computer analysis has
demonstrated targeted
signal penetration into
the joint.
Many BioniCare patients return to activities such as skiing, running and tennis.
Some osteoarthritis patients have returned to competitive levels that otherwise
seemed impossible. One BioniCare patient recovered to take first-place in his
age group in the Boston Marathon.
w w w. b i o n i c a r e . c o m
The BioniCare pulsed
electrical stimulation signal
received FDA clearance
in 2003 “as an adjunctive
therapy for reducing the
level of pain and symptoms
associated with osteoarthritis
of the knee and for overall
improvement of the knee
as assessed by the physician’s
global evaluation (see
clinical studies).”
The patented impulse
is a monophasic negative
spike delivered at 100Hz
This image is a reproduction of a computer-generated model of the electrical field delivered
by the BioniCare generator in a virtual human leg (courtesy of the University of Auckland).
BioniCare Delivery Systems
The BioniCare® System is offered in conjunction with the OActive® or Eagle OATM knee braces to provide the immediate
benefit of a proven mechanical unloading approach. A night-wrap is provided with each brace system to use BioniCare
while sleeping. The combination of bracing and BioniCare allows patients to achieve greater results in a shorter period
of time than any other treatment option.
Bionicare OActive® System:
• Single upright osteoarthritis knee brace
• Unique angle adjustment to optimize pain relief
• Low-profile, light weight design enhances comfort and compliance • Unique design provides necessary leverage for medial or lateral compartment unloading
• Lateral application avoids contra-lateral limb and tibial crest pressure issues
• Quick release buckles for easy removal
• Sili-grip liners and strap pads for best suspension
• Available in custom or off-the-shelf versions
• Includes BioniCare Night-Wrap
BioniCare Night-Wrap
• Easy to use
• Achieve additional hours of use while sleeping
Bionicare Eagle OATM System:
•
•
•
•
•
•
•
Double upright osteoarthritis knee brace
Active Thigh Cuff moves with muscles and soft tissue to maximize suspension and comfort
Maximum stabilization and correction provided by double upright frame
Light-weight design enhances comfort and compliance
Sili-grip strap pad for best suspension
Available as custom only
Includes BioniCare Night-Wrap
The knee joint’s lack of a blood,
nerve, or lymphatic supply led
researchers to hypothesize that
an electrical impulse is the body’s
mechanism to maintain joint health.
Due to the physical changes in the
osteoarthritic knee, the endogenous
electrical impulse is diminished.
BioniCare supplements this weakened
signal with an external one that is clinically
proven to reduce pain and restore function.
Clinical studies have shown significant
improvement even when severe osteoarthritis
is present. BioniCare is indicated for uni, bi,
and tri-compartmental osteoarthritis.
Comprehensive and convincing evidence for the BioniCare Knee System has been well-established
through five, peer-reviewed, scientific studies involving 1,200 patients in 88 clinical settings.
“Without the knee device I would have
had to have a total knee replacement.”
“At 68 years old, I can enjoy my life
without pain in my knee.”
Physician Global Evaluation: improvement from baseline over first four weeks, 53 time
compliant completers
“For me, it’s like a new life!”
2.5
2.3
Improvement (10 point VAS pain scale)
Patients experience significant relief of
pain and symptoms1
BioniCare Technology
The patented BioniCare Knee System delivers an imperceptible pulsed electrical signal that was designed specifically for
the treatment of pain, symptoms and the overall improvement of the osteoarthritic knee.
• Indicated specifically for knee osteoarthritis - FDA clearance received in 2003
• Non-drug, non-invasive treatment lowers cost and avoids side effects and risks associated with other treatments
• Testimonials show that BioniCare works for patients and gets them back to the activities that they enjoy
• Advanced technology electrodes eliminate the need for messy conductive gel while delivering the patented
BioniCare signal
2.3
2.0
2.0
1.5
130%
1.4
1.0
1.1
1.0
0.9
0.5
0.6
greater improvement
demonstrated by
BioniCare-treated
knee patients vs.
placebo. Both groups
kept on best medical
treatment throughout.
Active BioniCare Patients (N=32)
0
Baseline
Patients using placebo (N=21)
Week 1
p<0.013
Week 2
Week 3
Week 4
Deferring TKR surgery: 4-year study of patients with severe knee osteoarthritis whose
doctor recommended a TKR
Unlike all others
The unique BioniCare signal should not be confused with other types of stimulators that only block the body’s pain signals
and do not improve the knee. A healthy knee produces an electrical impulse upon weight-bearing, while in an arthritic
joint the strength of that impulse is significantly diminished. BioniCare delivers an electrical signal that mimics the natural
impulse and is clinically proven to be effective.
Patients NOT having Total Knee Replacement
100%
Deferral of total knee replacement surgery
established in four-year study led by
Johns Hopkins Orthopedic surgeons2
84%
76%
80%
69%
62%
60%
62%
67 %
40%
33%
20%
BioniCare patients deferring TKR
0%
Control patients deferring TKR
Year 1
Baseline
Patient Compliance at a glance
24%
Year 2
7%
Year 3
less likely to have
total knee replacement
surgery when treated
with a BioniCare Knee
Device vs. controls
Year 4
Personalized patient data and outcome responses can
now be tracked online.
BIONICARE® VS THE ALTERNATIVES
• The NEW BIO-2000 device records usage data and patient outcome
responses and wirelessly uploads the information via Bluetooth to
our website.
1.6
Large Effect Size (>1.0)
BioniCare with Bracing is the Most Effective
Treatment Option3
• Patients can print progress reports that can be shared at office visits
• Review usage and efficacy to assist in treatment planning
EFFECT SIZE
1.4
TOTAL KNEE REPLACEMENT
1.2
Pain
Pain Walking
0.8
Pain Stairs
0.6
Pain Sleeping
NSAIDs
Small Effect Size (0.2-0.5)
HYALURONATES
0.2
Physician's Global
BIONICARE OACTIVE
BIONICARE ALONE
0
BASELINE
www.bionicare.com
Patient Pain & Symptoms
48 Hour Pain
1
0.4
• Provides BioniCare and osteoarthritis resources for your patients
OUTCOME MEASURES
MONTH 1
MONTH 2
MONTH 3
MONTH 6
MONTHS
MONTH 12
Comprehensive and convincing evidence for the BioniCare Knee System has been well-established
through five, peer-reviewed, scientific studies involving 1,200 patients in 88 clinical settings.
“Without the knee device I would have
had to have a total knee replacement.”
“At 68 years old, I can enjoy my life
without pain in my knee.”
Physician Global Evaluation: improvement from baseline over first four weeks, 53 time
compliant completers
“For me, it’s like a new life!”
2.5
2.3
Improvement (10 point VAS pain scale)
Patients experience significant relief of
pain and symptoms1
BioniCare Technology
The patented BioniCare Knee System delivers an imperceptible pulsed electrical signal that was designed specifically for
the treatment of pain, symptoms and the overall improvement of the osteoarthritic knee.
• Indicated specifically for knee osteoarthritis - FDA clearance received in 2003
• Non-drug, non-invasive treatment lowers cost and avoids side effects and risks associated with other treatments
• Testimonials show that BioniCare works for patients and gets them back to the activities that they enjoy
• Advanced technology electrodes eliminate the need for messy conductive gel while delivering the patented
BioniCare signal
2.3
2.0
2.0
1.5
130%
1.4
1.0
1.1
1.0
0.9
0.5
0.6
greater improvement
demonstrated by
BioniCare-treated
knee patients vs.
placebo. Both groups
kept on best medical
treatment throughout.
Active BioniCare Patients (N=32)
0
Baseline
Patients using placebo (N=21)
Week 1
p<0.013
Week 2
Week 3
Week 4
Deferring TKR surgery: 4-year study of patients with severe knee osteoarthritis whose
doctor recommended a TKR
Unlike all others
The unique BioniCare signal should not be confused with other types of stimulators that only block the body’s pain signals
and do not improve the knee. A healthy knee produces an electrical impulse upon weight-bearing, while in an arthritic
joint the strength of that impulse is significantly diminished. BioniCare delivers an electrical signal that mimics the natural
impulse and is clinically proven to be effective.
Patients NOT having Total Knee Replacement
100%
Deferral of total knee replacement surgery
established in four-year study led by
Johns Hopkins Orthopedic surgeons2
84%
76%
80%
69%
62%
60%
62%
67 %
40%
33%
20%
BioniCare patients deferring TKR
0%
Control patients deferring TKR
Year 1
Baseline
Patient Compliance at a glance
24%
Year 2
7%
Year 3
less likely to have
total knee replacement
surgery when treated
with a BioniCare Knee
Device vs. controls
Year 4
Personalized patient data and outcome responses can
now be tracked online.
BIONICARE® VS THE ALTERNATIVES
• The NEW BIO-2000 device records usage data and patient outcome
responses and wirelessly uploads the information via Bluetooth to
our website.
1.6
Large Effect Size (>1.0)
BioniCare with Bracing is the Most Effective
Treatment Option3
• Patients can print progress reports that can be shared at office visits
• Review usage and efficacy to assist in treatment planning
EFFECT SIZE
1.4
TOTAL KNEE REPLACEMENT
1.2
Pain
Pain Walking
0.8
Pain Stairs
0.6
Pain Sleeping
NSAIDs
Small Effect Size (0.2-0.5)
HYALURONATES
0.2
Physician's Global
BIONICARE OACTIVE
BIONICARE ALONE
0
BASELINE
www.bionicare.com
Patient Pain & Symptoms
48 Hour Pain
1
0.4
• Provides BioniCare and osteoarthritis resources for your patients
OUTCOME MEASURES
MONTH 1
MONTH 2
MONTH 3
MONTH 6
MONTHS
MONTH 12
BioniCare Delivery Systems
The BioniCare® System is offered in conjunction with the OActive® or Eagle OATM knee braces to provide the immediate
benefit of a proven mechanical unloading approach. A night-wrap is provided with each brace system to use BioniCare
while sleeping. The combination of bracing and BioniCare allows patients to achieve greater results in a shorter period
of time than any other treatment option.
Bionicare OActive® System:
• Single upright osteoarthritis knee brace
• Unique angle adjustment to optimize pain relief
• Low-profile, light weight design enhances comfort and compliance • Unique design provides necessary leverage for medial or lateral compartment unloading
• Lateral application avoids contra-lateral limb and tibial crest pressure issues
• Quick release buckles for easy removal
• Sili-grip liners and strap pads for best suspension
• Available in custom or off-the-shelf versions
• Includes BioniCare Night-Wrap
BioniCare Night-Wrap
• Easy to use
• Achieve additional hours of use while sleeping
Bionicare Eagle OATM System:
•
•
•
•
•
•
•
Double upright osteoarthritis knee brace
Active Thigh Cuff moves with muscles and soft tissue to maximize suspension and comfort
Maximum stabilization and correction provided by double upright frame
Light-weight design enhances comfort and compliance
Sili-grip strap pad for best suspension
Available as custom only
Includes BioniCare Night-Wrap
The knee joint’s lack of a blood,
nerve, or lymphatic supply led
researchers to hypothesize that
an electrical impulse is the body’s
mechanism to maintain joint health.
Due to the physical changes in the
osteoarthritic knee, the endogenous
electrical impulse is diminished.
BioniCare supplements this weakened
signal with an external one that is clinically
proven to reduce pain and restore function.
Clinical studies have shown significant
improvement even when severe osteoarthritis
is present. BioniCare is indicated for uni, bi,
and tri-compartmental osteoarthritis.
The OActive® laterally applied
frame and hinge corrects for
either medial or lateral compartment and avoids contralateral limb contact during gait.
It’s perfect for bilateral brace
users as well as those with
limited room between their
thighs or knees during gait.
According to its FDA clearance, BioniCare® is the only treatment available that provides an overall
improvement to the osteoarthritic knee as assessed by the physician’s global evaluation. More than
5,000 physicians have treated over 80,000 osteoarthritis patients with the BioniCare Knee System and
the results have been outstanding. While the peer-reviewed, published scientific evidence supporting
the efficacy of BioniCare is compelling, the positive patient outcomes speak for themselves.
TWO ELECTRODES
BioniCare’s clinically
proven signal is delivered
through advanced technology electrodes that
avoid the need for messy
conductive gel. Extensive
computer analysis has
demonstrated targeted
signal penetration into
the joint.
Many BioniCare patients return to activities such as skiing, running and tennis.
Some osteoarthritis patients have returned to competitive levels that otherwise
seemed impossible. One BioniCare patient recovered to take first-place in his
age group in the Boston Marathon.
w w w. b i o n i c a r e . c o m
Indications For BioniCAre
History of BioniCare Technology
The BioniCare Knee System is indicated for use as an
adjunctive therapy in reducing the level of pain and
symptoms associated with osteoarthritis of the knee and
for overall improvement of the knee as assessed by the
Physician’s Global Evaluation (clinical studies).
1985
1986
1990
1993
1997
1999
2003
Contraindications
–
–
–
–
–
–
–
FDA IDE G850158 for arthritis trials
Osteoarthritis and RA trials initiated
FDA PMA P900055 filed for OA Knee
FDA Non-Significant Risk Letter
FDA 510(k) Clearance for OA Knee
FDA 510(k) Clearance for RA Hand
FDA 510(k) Clearance for Dual OA Knee
• Do not use the BioniCare Knee System for any electrode
placement that applies current to the carotid sinus
(neck) region.
• Do not use the BioniCare Knee System for any electrode
placement that causes current to flow transcerebrally
(through the head).
References
1
Zizic TM, Hoffman KC, et al. “Treatment of Osteoarthritis of the Knee with
Pulsed Electrical Stimulation” Journal of Rheumatology 1995, Vol 22
Issue 9, Pages 1757-1761
2
Mont MA, Hungerford DS, et al. “Pulsed Electrical Stimulation to Defer TKA
in Patients with Knee Osteoarthritis.” Orthopedics. October 2006 (10):
887-892
3
Harrington TJ, et al. Synergy Paper, “New Options for Treating Osteoarthritis
of the Knee.” Supplement to Rheumatology News Nov 2011.
• Do not use the BioniCare Knee System when pain
syndromes are undiagnosed until etiology is established.
Precautions
Isolated cases of skin irritation may occur at the site of
electrode placement following long-term application.
Adverse Reactions
Skin irritation and electrode burns are potential adverse
reactions. Patients with skin irritation / reactions should
be monitored.
WARNINGS
• The BioniCare Knee System must be used only as
prescribed and applied only to the knee.
• Patients with demand style cardiac pacemakers should
consult with their physician prior to use of this system.
• The safety of the BioniCare Knee System for use during
pregnancy or birth has not been established.
• The BioniCare Knee System is not effective for pain
of central origin (including headache).
• Use only under the continued supervision of a physician.
• Keep out of reach of children.
• Electronic monitoring equipment (such as ECG monitors
and ECG alarms) may not operate properly when the
BioniCare Knee Device is in use.
Indications For OACTIVE and Eagle OA
• Mild to severe unicompartmental knee osteoarthritis.
• Medial or lateral compartment.
WARNINGS
If you experience pain, swelling, sensation changes,
or unusual reactions while using this product, contact
VQ OrthoCare’s Patient Care department at
800.452.7993 or consult a physician.
CAUTION
Federal law restricts this device to sale by or
on the order of a practitioner licensed by the
law of the State in which he/she practices to
use or order the use of the device.
www.bionicare.com
18011 Mitchell South • Irvine, CA • 92614
800.266.6969 • www.vqorthocare.com
© 2011 VisionQuest Industries, Inc.
VQO511536REVG
Proven non-invasive treatment for OA